Second corrigenda to the MDR and IVDR; Vigilance Reporting – updated Manufacturer Incident Reporting (MIR) forms
E-News: 23 January 2020
Client Communication: 23 January 2020
Second corrigendum to the MDR
The EU Commission has now published the second corrigendum to the MDR in the Official Journal of the EU (OJEU).
The key change to the MDR states that devices classified as Class I under the MDD can continue to be placed on the market until the 26 May 2024 if the following conditions are met:
- The manufacturer has issued a ‘Declaration of Conformity’ under the MDD prior to 26 May 2020
- The devices require notified body involvement under the MDR
- There are no significant changes in the design or intended purpose of the devices after the 26 May 2020
What impact will this have on manufacturers?
This mainly affects manufacturers with Class I devices under the MDD such as software devices and re-usable surgical instruments which, due to up-classification, will require notified body involvement under the MDR. The corrigendum extends the date of application of MDR for such devices to May 2024.
BSI still recommends that manufacturers start submitting their MDR applications for these devices as soon as they are ready and not wait until the May 2024 deadline.
As a reminder, the medical devices that will still need to be compliant to the MDR by the 26 May 2020 for continued market access include:
- Class I devices under the MDD that will continue to be Class I under the MDR and hence do not need any notified body involvement
- Custom-made Class III implantable devices
- Devices that utilize human tissue derivatives
- Article 117 drug-device combinations
- Annex XVI devices without a medical purpose (as an exception, the date MDR will apply to these devices will be six months from the date of the Annex XVI common specification being adopted instead of the 26 May 2020)
Second corrigendum to the IVDR
The EU Commission has also published the second corrigendum to the IVDR in the Official Journal of the EU (OJEU).
The key change to the IVDR affects devices that fall under Rule 2 of Annex VIII, which includes devices intended to be used for blood grouping or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion, transplantation or cell administration.
This rule states that these devices are Class C, unless they are measuring any of the following markers: ABO, Rhesus, Kell, Kidd or Duffy systems; in which case they are classified as Class D. The corrigendum clarifies that this rule also includes devices intended to be used for determining foeto-maternal blood group incompatibility.
Vigilance Reporting – updated Manufacturer Incident Reporting (MIR) forms
As of January 2020, manufacturers are now required to use the updated MIR form (version 7.2) for submitting vigilance incident reports to the Competent Authorities (CAs). Version 7.1 of the MIR form may be used, as an exception, until the end of March 2020. Help text, changelog, and guidance on implementation of the updated MIR form in manufacturers’ databases can be found on the European Commission website.
BSI’s Terms and Conditions of Contract require manufacturers to submit copies of their incident reports to us via the BSI e-vigilance portal. The portal has now been updated to accept the new version (Version 7.2) of the MIR form, and will stop accepting the previous versions of the MIR form at the end of January 2020.
Please ensure that copies of any incident reports already submitted to CAs utilizing previous versions of the MIR form are submitted to BSI via the e-vigilance portal by the end of this month.
Please contact your scheme manager if you have any queries.
Yours sincerely,
Dr Jayanth Katta
Regulatory Lead, Regulatory Services (Medical Devices)
